Pre-Workout on Exercise Performance and Cognition



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 40
Updated:3/16/2015
Start Date:October 2014
End Date:January 2015

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A Randomized, Double-Blind, Crossover Clinical Trial Comparing the Effects of Four Pre-Workout Beverages on Muscular Strength and Endurance and Cognitive Performance in Healthy Adult Males

The purpose of this study is to determine the effects of four different pre-workout
beverages as compared to placebo on muscular strength and endurance, perceived energy and
cognitive performance in healthy adult males.


Inclusion Criteria:

1. Males, aged 18 to 40 years

2. Subject has a waist circumference ≤ 97 cm.

3. Subject is a non-smoker.

4. Subject is in good health and appropriate for exercise as determined by physical
examination, medical history and ECG.

5. Subject is weight training for the 6 months prior to starting the trial.

6. Subject agrees to not use any new vitamins and/or minerals until after study
completion and to not take any vitamins and/or minerals 24 hours prior to the test
visits.

7. Subject agrees to not use any dietary or herbal supplements until after study
completion. A 7-day washout is allowed for study inclusion.

8. Subject is willing and able to comply with the protocol including:

- Attending 5 visits each of which is approximately 4 hours long;

- Refraining from caffeine, over-the-counter medications and alcohol for the 24
hours prior to the test visits;

- Refraining from weight training for the 48 hours prior and refraining from any
exercise other than weight training for 24 hours prior to the test visits;

- Refraining from taking any dietary or herbal supplements throughout the study.

9. Subject is able to understand and sign the informed consent to participate in the
study.

Exclusion Criteria:

1. Subject has any of the following medical conditions:

- active heart disease

- uncontrolled high blood pressure (≥ 140/90 mmHg)

- renal or hepatic impairment/disease

- Type I or II diabetes

- bipolar disorder

- pulmonary disease (including current asthma)

- Parkinson's disease

- Seizure disorder

- unstable thyroid disease

- immune disorder (such as HIV/AIDS)

- active psychiatric disorders (including anxiety disorders)

- bleeding disorders

- gastrointestinal ulcer disease

- any medical condition deemed exclusionary by the Principal Investigator (PI)

2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which
make(s) resistance weight training contraindicated.

3. Subject has a history of cancer (except localized skin cancer without metastases)
within 5 years prior to screening.

4. No prescription or chronic medication use allowed without PI discretion.

5. Subject is currently taking and unwilling to refrain from taking any over-the-counter
stimulant medications/supplements (see section 2.6.2); seven-day washout required for
study inclusion.

6. Subject is currently taking and unwilling to refrain from taking any over-the-counter
allergy or asthma medication containing pseudoephedrine or ephedrine (see section
2.6.2); seven-day washout required for study inclusion.

7. Subject has an allergy to milk and phenylalanine, or any of the ingredients in the
test product (see section 3.2.1).

8. Subject reports sensitivity to caffeine and/or beta-alanine.

9. Subject reports being a regular caffeine consumer defined as consuming > 600 mg of
caffeine per day.

10. Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST,
AP being ≥ two times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl
or other clinically significant abnormal clinical laboratory value per PI discretion.

11. Subject has a clinically relevant abnormality as defined by the PI or interpreting
physician with respect to the ECG.

12. Subject has a QTcB interval > 450 msec.

13. Subject has a history of drug or alcohol abuse in the past 12 months.

14. Subject has any condition or abnormality that, in the opinion of the investigator,
would compromise the safety of the subject or the quality of the study data.

15. Subject has taken an investigational product within 30 days of the first exercise
test visit (visit 2).
We found this trial at
1
site
Miami, Florida
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Miami, FL
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